KVISTGAARD, Denmark, Nov. 29, 2007-Bavarian Nordic reports the
successful completion of a large, placebo-controlled Phase II trial
in 745 healthy subjects who received either one or two doses of
Imvamune third-generation smallpox vaccine. The results of this
study are seen as the pivotal step on the path to moving into Phase
III registration trials in order to achieve a BLA for healthy
subjects.

The study, together with other Phase II studies with
IMVAMUNE® in immune-compromised persons, is pivotal for
obtaining an Emergency Use Authorization (EUA). The company still
expects to receive approval of the EUA application in second half
of 2008.

Traditional smallpox vaccines are associated with a high risk of
heart complications (e.g. myo-/pericarditis) in approximately 1 in
every 150 people vaccinated for the first time. Therefore, aside
from assessing general immune response and safety, the primary
focus of this study was to compare cardiac safety in the different
study groups following vaccination with IMVAMUNE®. The large
amount of safety data collected from the 745 people who completed
this study confirmed the excellent safety and tolerability profile
of IMVAMUNE®. Importantly, vaccinations with IMVAMUNE® did
not result in any clinically significant abnormal cardiac findings
and no cardiac events (e.g. cases of myo-/pericarditis) that have
been reported for traditional smallpox vaccines.

Moreover, vaccinations with IMVAMUNE® resulted in
seroconversion (detectable immune responses) in almost all subjects
(98.9%) previously not vaccinated against smallpox. Similarly, a
single vaccination with IMVAMUNE® boosted the immune responses
in the majority of people whom had historically already been
vaccinated against smallpox.

This study completes the Phase II development of IMVAMUNE®
in healthy subjects and this now leads to planning with the FDA on
the design of the Phase III study that is planned to commence in
2008.

Anders Hedegaard, President & CEO, said: "We are very
satisfied with these results which brings us closer to our EUA
application which represents an important milestone in the
development of IMVAMUNE® as the modern smallpox vaccine the
world has been waiting for."